Intellectual property & publically funded research B ayh-Dole & the EU

1. Belgrade 30 October 2012 Intellectual property & publically funded researchBayh-Dole & the EU Alison Campbell OBE PhD RTTP

2. My background Independent consultant in technology transfer & knowledge transfer International client base of universities and research institutes 20 years leading technology transfer and research management in research intensive organisations Industry bioscientist Non Executive Director of PraxisUnico Chair of PraxisUnico training Advisory roles with UK research funding agencies OBE for service to knowledge transfer, 2010

3. PraxisUnico • Is the UK’s leading Technology Transfer Association (top 88% of UK universities are PraxisUnico members) • More than 97% of UK university research funding is spent in PraxisUnico member institutions • Is structured to make the biggest impact for our members and customers.  • Is run by the UK’s leading Technology Transfer practitioners on a voluntary basis

4. Sharing best practice • With an International institutional member base PraxisUnico delivers • Annual conference • Events • Networking • Training • And leads on advocacy with key opinion leaders and policy makers for the sector

5. PraxisUnico training • Technology & knowledge transfer programmes geared to those working at the interface of academia and industry • To date delivered in • UK | India | China | Brazil | Colombia | Japan | South Africa | Australia| Mainland Europe | Ireland • 2 days – 1 week programmes • Fundamentals of Technology Transfer • Advanced Licensing • New Venture Creation • Consultancy • Research Contracts • Business Development • TT for academics • Taught by expert knowledge transfer professionals • 2,500 individuals have been trained through PraxisUnico

6. Alliance of Technology Transfer professionals (ATTP) • Founded by the major global TT organisations to recognise the profession • Individuals apply to become a Registered Technology Transfer Professional (RTTP) • International peer review Association of University Technology Managers (AUTM) | PraxisUnico | Knowledge Commercialisation Australasia (KCA) | Association of Science and Technology Professionals (ASTP)

7. ATTP global coverage

8. Bayh-Dole Act • P.L. 96-517, Patent and Trademark Act Amendments of 1980 • Enacted on December 12, 1980 • Created a uniform patent policy amongst US federal agencies that fund research • Enabled small businesses and non-profit making entities including universities to retain title to inventions made under federally-funded research programmes • The legislations was co-sponsored by Senators Birch Bayh of Indiana and Robert Dole of Kansas

9. Main provisions of the Bayh-Dole Act • Non-profits, including universities, and small businesses may elect to retain title to innovations developed under federally-funded research programmes • Universities are encouraged to collaborate with commercial concerns to promote the utilisationof inventions arising from federal funding • Universities are expected to file patents on inventions they elect to own • Universities are expected to give licensing preference to small businesses • The government retains a non-exclusive license to practice the patent throughout the world • The government retains march-in rights

10. Requirements on recipients of federal research funding • Report each disclosed invention to the funding agency • Elect to retain title in writing within a statutorily prescribed timeframe • File for patent protection • Grant the federal government a non-exclusive, non-transferable, irrevocable, paid-up licenceto practice or have practiced on its behalf throughout the world • Actively promote and attempt to commercialisethe invention • Not assign the rights to the technology, with a few exceptions • Share royalties with the inventor • Use any remaining income for education and research

11. Exclusions to Bayh-Dole • If an invention is made outside the research activities of the federally funded research "without interference with or cost to the government-funded project," then the invention does not fall under the Act • The invention does not fall under the Act if it arises in closely related research outside the "planned and committed activities" of the federally funded project, and the closely related research does not "diminish or distract from the performance" of the federally funded project • Many institutions have assumed that where federal funds have been used anywhere in a lab, an invention is governed by the Act

12. March-in rights • To date, no federal agency has exercised its march-in rights • Despite some petitions by industry • A march-in decision could have adverse effects on federal efforts to encourage firms to commercialisefederally funded research.

13. Bayh-Dole was good, right? Yes but……

14. ‘Today’s universities function more like corporate research laboratories…….In trying to power the innovation economy, we have turned America’s universities into cut-throat business competitors, zealously guarding the very innovations we so desperately want behind a tangled web of patents and royalty licenses.’’ New York Times,2008

15. Ownership of IPR in EU Universities Confused and fragmented

16. EU National IPR regulations

17. And even then…… • Academics may own the IPR and are obliged to assign to the university or; • Academics may own the IPR and the university must ask for assignment within a defined period od time (differs) or; • The university may own all IPR created by its academics unless it is wholly outside of their normal duties or; • The university may own IPR created by its academics that is not funded by the university itself or; • Etc.

18. And in the USA • Academics never owned their own IPR • It was owned by the government • And this was thought to inhibit commercialisation • Bayh-Dole brought IPR commercialisation closer to the academic • But didn’t give the rights to them

19. And then we have EU university by-laws….. • Different treatment of IPR in different cases • E.g. where the work has been done with external parties such as a company • Different incentives and inventor reward schemes

20. So what makes a difference? • National expectations • Funder requirements • University culture • Professional support systems • The academics

21. Boosting commercialisation • 10 years ago, EU performance in commercialisation was reviewed. Problems cited included: • a continued over-reliance on a ‘linear’ approach to innovation, which assumed that investment in the supply side would automatically result in marketable innovations downstream; • measuring academic success on the basis of research papers or academic citations, with intellectual property creation, for example, often not given parity of esteem as a research publication; • peer review (and lack of external examination), which may tend to prevent academic networks opening up to external scrutiny; and • academics being given insufficient time, or promotion incentives to engage in commercial activities. The European Union, Economic Policy Committee, Working Group on Research and Development, Report on Research and Development, EPC/ ECFIN/01/777-EN, 34 (January 22, 2002). • Has this changed?

22. Experience from the UK • 1949 National Research Development Corporation(NRDC) • Central office commercialising government funded research • 1987 rights to government funded IPR given to universities • 1990s rise of the TTO created to focus on IPR, licensing and spin-outs • 2000s TT broadened to Knowledge Transfer • wider relationships with business

23. Ways this has been encouraged • Higher Education Innovation Fund (HEIF) • 2001 – present • Support for creation of KTOs in all universities • Strategy, metrics, reporting • 2004 Lambert Report, Technology Strategy Board • 2005 Lambert Agreements • 2008 emergence of the impact agenda • Funding Councils, Research Councils • Award criteria, development awards, impact competitions etc. • 2014 Research Excellence Framework (REF) • 20% weighted on impact

24. Shift in expectations Research innovation and impact

25. Is it working? Unico /Library House Report 2009 “[Views of US colleagues] suggest that, compared to the US, the UK is advanced in both the measurement and variety of knowledge transfer activities that are undertaken in UK universities.” Three quarters of UK academics now engage in some form of external activity; nearly a fifth provide consultancy services and 13% have taken out a patent

26. In summary, our objectives should be…. • To make it easy and transparent for • Licensees • Investors • Commercial partners • The TTO • The academic • To engage in knowledge transfer and commercialisation

27. Will an EU Bayh-Dole fix this? • No • But • Setting the right national and local frameworks • And providing on the ground support • To allow academics to adopt new behaviours • Will have the greatest effect

29. Contact details www.alisoncampbellassociates.com www.praxisunico.org.uk www.attp.info alison@alisoncampbellassociates.com